Application 064032

Type
ANDA
Sponsor
HOSPIRA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAZICEFCEFTAZIDIMEINJECTABLE;INJECTION1GM/VIALNoNo
002TAZICEFCEFTAZIDIMEINJECTABLE;INJECTION2GM/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A064032-001TAZICEFCEFTAZIDIME1GM/VIALINJECTABLE / INJECTIONAP1993-10-31
A064032-002TAZICEFCEFTAZIDIME2GM/VIALINJECTABLE / INJECTIONAP1993-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A064032-001AP
A064032-002AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-31bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064032-001TAZICEF1GM/VIALINJECTABLE / INJECTIONAP1993-10-31782e0a99824c…
2021-12-28 21:50 UTC2021-12A064032-002TAZICEF2GM/VIALINJECTABLE / INJECTIONAP1993-10-31782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A064032-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A064032-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064032-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A064032-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A064032-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A064032-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064032-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A064032-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064032-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A064032-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064032-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A064032-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064032-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A064032-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064032-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A064032-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064032-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A064032-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A064032-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A064032-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064032-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A064032-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064032-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A064032-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064032-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A064032-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A064032-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A064032-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064032-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A064032-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A064032-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A064032-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A064032-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A064032-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A064032-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A064032-002AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A064032-001AP1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A064032-002AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A064032-001AP1782e0a99824c…
2021-12-28 21:50 UTC2021-12A064032-002AP1782e0a99824c…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TAZICEFCEFTAZIDIMEHospira, Inc.9b73979c-c95a-4433-0a9d-f9cea3cb557f2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 064032
application number: ANDA064032
ndc (product): 0409-5093
ndc (product): 0409-5092

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-5092TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5092TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5092TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5092TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5092TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5092TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5092TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5092TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5093TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5093TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5093TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5093TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5093TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5093TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5093TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent
0409-5093TAZICEFCEFTAZIDIMEHospira, Inc.ANDACurrent